DRAFT: FOR INFORMAL PUBLIC COMMENT STATE …mhcc.maryland.gov/.../home/...Chapter_for_Informal_Public_Comments.pdfFACILITIES AND SERVICES: HOME HEALTH AGENCY SERVICES ... E. Overview

DRAFT: FOR INFORMAL PUBLIC COMMENT

STATE HEALTH PLAN FOR

FACILITIES AND SERVICES:

HOME HEALTH AGENCY SERVICES

COMAR 10.24.16

Written Public Comments Accepted until October 30, 2015

Send to: Cathy Weiss, Program Manager

Center for Health Care Facilities Planning and Development

Maryland Health Care Commission

4160 Patterson Avenue

Baltimore, Maryland 21215

Email: [email protected]

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Table of Contents

Page

.01 Incorporation by Reference............................................................................................... 1

.02 Introduction ....................................................................................................................... 1

A. Purposes of the State Health Plan for Facilities and Services .............................. 1

B. Legal Authority for the State Health Plan............................................................. 1

C. Organizational Setting of the Commission ........................................................... 2

D. CON Applicability to a Home Health Agency ..................................................... 2

E. Overview of the Home Health Agency Chapter to the State Health Plan ............ 3

.03 Issues and Policies: Home Health Agency Services ........................................................ 5

A. Background ........................................................................................................... 5

B. Availability and Accessibility of Quality Home Health Agency Services ........... 6

C. Home Health Agency Quality Measures and Performance .................................. 7

D. Home Health Agency Data Collection and Public Reporting .............................. 9

.04 Need Determination for Home Health Agency Services ................................................ 11

.05 Use of Multi-Jurisdictional Regions in CON Review of HHA Services ........................ 12

.06 Certificate of Need Application Acceptance Rules: Home Health Agency Services .... 13

A. Jurisdictional Need.............................................................................................. 13

B. Qualified Applicants ........................................................................................... 13

C. Qualifying Criteria for All Applicants ................................................................ 13

D. Performance-Related Qualifying Criteria ........................................................... 14

.07 Publication of Home Health Agency Quality Measures and Performance Levels

for Qualified Applicants ................................................................................................. 15

A. Review and Comment on Quality Measures, Performance Levels and

Public Notice ....................................................................................................... 15

B. Quality Measures for Maryland Medicare-certified HHAs ................................ 15

C. Quality Measures for Non-Maryland Medicare-certified HHAs ........................ 15

D. Quality Measures for Licensed and Accredited Hospital,

Nursing Home or Maryland Residential Service Agency (RSA) Providing

Skilled Nursing Services ..................................................................................... 15

DRAFT for Informal Public Comment

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Draft for Informal Public Comment

Table of Contents

Page

.08 Certificate of Need Review Standards for Home Health Agency Services .................... 17

A. Service Area ........................................................................................................ 17

B. Populations and Services .................................................................................... 17

C. Financial Accessibility ........................................................................................ 17

D. Fees and Time Payment Plan .............................................................................. 17

E. Charity Care and Sliding Fee Scale .................................................................... 17

F. Financial Feasibility ............................................................................................ 18

G. Impact ................................................................................................................. 18

H. Financial Solvency .............................................................................................. 19

I. Linkages and Other Service Providers ................................................................ 19

J. Discharge Planning ............................................................................................. 19

K. Data Collection and Submission ......................................................................... 19

.09 Certificate of Need Preference Rules in Comparative Reviews ..................................... 20

A. Performance on Quality Measures ...................................................................... 20

B. Proven Track Record in Serving All Payor Types and the Indigent................... 20

C. Proven Track Record in Providing a Comprehensive Array of Services ........... 20

.10 Gradual Entry of New Market Entrants .......................................................................... 21

.11 Acquisition of Home Health Agencies ........................................................................... 22

A. Acquisition of Authority to Serve Certain Jurisdictions ..................................... 22

B. Consideration of HHA Acquisition .................................................................... 22

C. Commitment to Serve All Payor Types and the Uninsured ................................ 22

D. Acquisition of the Entire HHA ........................................................................... 22

E. Acquisition of an HHA with Ongoing CON Conditions .................................... 22

F. Information Required for a Determination of Coverage for an

HHA Acquisition ................................................................................................ 22


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Table of Contents

Page

.12 Merger or Consolidation of HHAs ................................................................................. 24

A. Jurisdictional Authority ...................................................................................... 24

B. Commitment to Serve All Payor Types and Uninsured...................................... 24

C. Merger of HHAs with Ongoing CON Conditions .............................................. 24

D. Public Interest Finding ........................................................................................ 24

.13 Definitions....................................................................................................................... 25


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.01 Incorporation by Reference. This Chapter is incorporated by reference in the Code of

Maryland Regulations.

.02 Introduction.

A. Purposes of the State Health Plan for Facilities and Services.

The Maryland Health Care Commission (Commission) has prepared this Chapter of the State

Health Plan for Facilities and Services (State Health Plan) to ensure that actions by the

Commission are guided by the objective of meeting the current and future needs of Maryland

residents.

The State Health Plan serves two purposes:

(1) It establishes health care policy to guide the Commission’s actions. Maryland law

requires that all State agencies and departments involved in regulating, funding, or planning for

the health care industry carry out their responsibilities in a manner consistent with the State

Health Plan and available fiscal resources.

(2) It is the foundation for the Commission’s decisions in its regulation of health care

facilities and services. These programs ensure that changes in health care facilities and services

are appropriate and consistent with the Commission’s policies. The State Health Plan articulates

the policies guiding the Commission’s regulation of health care facilities and services,

establishes the criteria and standards that state the Commission’s expectations about the facility

or service development proposals it considers, and may contain methodologies that forecast need

or demand for health care facilities or services, to inform the Commission and the public about

appropriate considerations for Certificate of Need (“CON”) decisions.

The State Health Plan should provide a vision for positive change in the delivery of health care

services. It should provide useful guidance for resource allocation decisions that appropriately

balance the population’s need for available, accessible, affordable, and high quality health care

services.

B. Legal Authority for the State Health Plan.

The State Health Plan is adopted under Maryland’s health planning law, Health-General Article

§19-114, et seq., Maryland Code Annotated (Health-General). This Chapter partially fulfills the

Commission’s responsibility to adopt a State Health Plan at least every five years and to review

and amend the State Health Plan as necessary. Health-General §19-118(a)(2) provides that the

State Health Plan shall include:

(1) The methodologies, standards, and criteria for Certificate of Need review; and

(2) Priority for conversion of acute care capacity to alternative uses where appropriate.


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C. Organizational Setting of the Commission.

The Commission is an independent agency, which is located within the Department of Health

and Mental Hygiene for budgetary purposes. The purposes of the Commission, as enumerated at

Health-General §19-103(c), include responsibilities to:

(1) Develop health care cost containment strategies to help provide access to appropriate

quality health care services for all Marylanders, after consulting with the Health Services Cost

Review Commission; and

(2) Promote the development of a health regulatory system that provides, for all

Marylanders, financial and geographic access to quality health care services at a reasonable cost

by advocating policies and systems to promote the efficient delivery of and improved access to

health care services, and enhancing the strengths of the current health care service delivery and

regulatory system

Health-General §19-110(a) provides that the Secretary does not have power to disapprove or

modify any regulation, decision, or determination that the Commission makes regarding or based

upon the State Health Plan. The Commission has sole authority to prepare and adopt the State

Health Plan and to issue Certificate of Need decisions and exemptions based on the State Health

Plan. Health-General §19-118(e) provides that the Secretary of Health and Mental Hygiene shall

make annual recommendations to the Commission on the State Health Plan and permits the

Secretary to review and comment on the specifications used in its development. The Commission

pursues effective coordination with the Secretary and State health-related agencies in the course

of developing the State Health Plan and plan amendments.

D. CON Applicability to a Home Health Agency.

Under Heath-General §19-120(f), a Certificate of Need (CON) is required before a new health

care facility is built, developed, or established. The definition of health care facility, found at

Health-General 19-114(d), includes a home health agency (HHA). More specifically, Health-

General §19-120(j)(2)(iii)4 provides that a Certificate of Need is required prior to the

“[e]stablishment of a … home health program ….” A Certificate of Need is also required for an

existing Maryland HHA to expand its authority to serve clients in a jurisdiction not previously

authorized to serve, as provided in Health-General §19-120(j)(3)(ii). A CON is required

“[b]efore an existing home health agency or health care facility establishes a home health agency

or home health care service at a location in the service area not included under a previous

certificate of need or license.” Also under Health-General §19-120(k) (2), a capital expenditure

by a health care facility that exceeds an applicable capital expenditure threshold requires a CON.


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The Commission’s procedural regulations, COMAR 10.24.01.02 - .03, describe the scope of

CON regulation of home health agency services. A CON is required for: (1) the establishment

of a home health agency; (2) the establishment of a new subunit by an existing home health

agency; (3) the expansion of a home health agency into a jurisdiction that the agency was not

previously authorized to serve; (4) a transfer of ownership of a subunit or a facility based home

health care service of an existing health care facility that separates the ownership of the subunit

from the home health agency or home health care service that established the subunit; and (5) a

capital expenditure by a home health agency that exceeds the applicable capital expenditure for

this category of health care facility.

A CON is not required for the acquisition of an existing licensed home health agency, as long as

the type or scope of services provided by the home health agency being sold is not changed. A

merger or consolidation of two or more licensed home health agencies reducing the supply of

agencies operating in Maryland requires the Commission’s issuance of an exemption from CON

review, consistent with COMAR 10.24.01.04.

E. Overview of the Home Health Agency Chapter of the State Health Plan.

This Chapter of the State Health Plan implements an approach to regulating the development

and expansion of HHA services in Maryland that is based on ensuring consumer choice of high

quality providers in which better performance by HHAs is encouraged by development and

expansion opportunities. The first step in this regulatory process is the determination of whether

jurisdictional populations or multi-jurisdictional regional populations need new HHA service

providers, based on certain qualifying characteristics as described in Regulation .04 of this

Chapter. Periodically, the Commission will evaluate the characteristics of jurisdictions using the

qualifying criteria described in Regulation .04 and establish project review cycles, as described

in Regulation .05 of this Chapter, so that qualified applicants could propose meeting the

identified population need.

The second step in the process is qualification of applicants described in Regulation .06 of this

Chapter. Only an applicant that demonstrates the ability to perform well in the delivery of HHA

services may submit an application that is capable of being docketed for review. Because quality

and performance measures are evolving, the qualifying criteria that will be used in a given

review cycle will be considered by the Commission and posted before any given review cycle

begins. The Commission will publish proposed quality measures and performance levels for

review and comment before officially establishing the criteria as applicable to a review cycle. As

described in Regulation .07, the Commission will choose quality measures that are important,

feasible, scientifically sound, and actionable, including performance measures that: (1) are of

importance to consumers, providers, and health officials; (2) are endorsed by a nationally

recognized organization engaged in health care quality and performance measurement such as

the National Quality Forum (NQF); (3) apply to most Maryland home health agencies; and (4)


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show a reasonable amount of variation among HHAs without excessive random variation over

time.

Upon determination that an applicant has met all the applicable minimal qualifications, including

performance-related criteria, as described in Regulations .06 and .07 of this Chapter, its

application will be considered for docketing. After docketing, the next step in the regulatory

process will be the review of the qualified CON applications. Compliance or consistency with

the CON review standards found in Regulation .08 and the general review criteria found in

COMAR 10.24.01.08G will be determined, either by a Commissioner serving as reviewer in a

contested or comparative review or by Commission staff in an uncontested or non-comparative

review.

The review process shall use preference rules, as described in Regulation .09 of this Chapter, in

comparative reviews where the number of qualifying applicants exceeds the number of new

projects that it is reasonable to authorize simultaneously for a jurisdiction or multi-jurisdictional

region. The preference rules will be used to determine which among several proposed projects

are likely to best meet the needs identified. Such determination may be necessary in order to

allow for gradual growth in the number of HHAs permitted to ensure that existing markets can

absorb new entrants without destabilizing the existing base of HHAs and without straining the

labor market or other resources. Additionally, such limitations will provide new market entrants

with a better chance for success by avoiding saturation of the existing market with additional

providers. Rules permitting gradual entry of new market entrants are described in Regulation .10.

Because acquisitions of HHAs that fall outside the scope of CON review can profoundly affect

the manner in which HHA services are delivered, Regulation .11 of this Chapter specifies

procedural rules that are intended to help assure that acquisitions of HHAs do not result in

reductions in the availability or accessibility of HHA services for any class of patient, reduced

quality of care, or the introduction of HHA owners and operators of questionable character and

competence.

Regulation .12 addresses procedural rules used in reviewing requests for an exemption from

CON, in the case of proposed mergers or consolidation of two or more HHAs. The procedural

rules under Regulations.11 and .12 build on the generic rules governing acquisitions and

exemptions from CON at COMAR 10.24.01.03 and .04 and are intended to assure the

maintenance of access to HHA services for all patients, greater transparency, and improved

accountability whenever changes in the supply, distribution, or ownership of HHAs occur.


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.03 Issues and Policies: Home Health Agency Services

A. Background

In Maryland, a variety of licensed entities provide home care services to sick or disabled persons

in their places of residence. In addition to HHAs, Maryland also licenses residential service

agencies (RSAs) and nursing referral service agencies (NRSAs).1 The Commission regulates

only one of these entities, home health agencies, through its Certificate of Need program.

Maryland law2 defines a home health agency as a health-related institution, organization, or part

of an institution that:

(1) Is owned or operated by 1 or more persons, whether or not for profit and

whether as a public or private enterprise; and

(2) Directly or through a contractual arrangement, provides to a sick or disabled

individual in the residence of that individual, skilled nursing services, home

health aide services, and at least one other home health care service that are

centrally administered.

Only a home health agency that meets Maryland licensure requirements, found at COMAR

10.07.10.02, may be certified to receive Medicare reimbursement. Types of home health services

covered by Medicare include the following six major disciplines: part-time or intermittent skilled

nursing;3 home health aide; physical therapy; occupational therapy; speech therapy; and medical

social services. A patient is eligible for the Medicare home health benefit if the patient: is

homebound;4 is under the care of a physician; is receiving services provided under a plan of care

established by a physician; and, requires skilled nursing care on an intermittent basis or

physical therapy or speech therapy services, or has a continued need for occupational therapy.5

1 Home health agencies are licensed under COMAR 10.07.10; Residential Service Agencies under COMAR

10.07.05, and Nursing Referral Service Agencies under COMAR 10.07.07. 2 Health–General § 19-401(b). 3 Medicare defines “part-time” as fewer than eight hours per day; “intermittent” means from as much as every day

for recurring periods of 21 days – if there is a predictable end to the need for daily care – to as little as once every 60

days. 4 To be homebound and considered “confined to the home” means you have trouble leaving your home due to your

illness or injury; leaving your home is not recommended because of your medical condition; and, you are unable to

leave your home because it is a major effort and assistance is required. A doctor must certify that the patient is

homebound. Department of Health & Human Services, CMS; CMS Manual System Pub. 100-2 Medicare Benefit

Policy, Transmittal 192, August 1, 2014 5Department of Health & Human Services (DHHS), Centers for Medicare & Medicaid (CMS), Medicare Benefit

Policy Manual, CMS Pub. 110-2.


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B. Availability and Accessibility of Quality Home Health Agency Services.

Each Maryland HHA, for the most part, has specified authority to serve clients in designated

jurisdictions. An agency’s potential size and service volume is dependent on the number of

authorized jurisdictions and the population of those jurisdictions. However, some HHAs do not

actually serve all of the jurisdictions which they are authorized to serve. For example, based on

FY 2013 data reported by the agencies in response to the Commission’s annual HHA Survey,

while nine agencies (18%) have authority to serve 11 or more jurisdictions, only five of those

agencies (10%) actually served at least one client in 11 or more jurisdictions. In FY 2013, 80

percent of the 50 general HHAs were authorized to serve more than one jurisdiction.

Availability of, and access to, HHA services is a function of both the supply of agencies and the

geographic distribution of agencies. There are variations in the geographic distribution of HHAs,

as measured by the number of agencies per jurisdiction across Maryland. As would be expected,

the majority of agencies operate in the most populous areas of Maryland – the Baltimore

metropolitan area,6 the suburban Washington, D.C. counties of Montgomery and Prince

George’s, and exurban Carroll and Frederick Counties. Client use rates per 1,000 population (all

ages) ranged from a regional low of 12.9 in Southern Maryland to a regional high of 23.7 on the

Eastern Shore in FY 2013.

Current law requires that HHA services regulation be implemented on a jurisdictional basis. For

rural or less densely populated areas of the State, successfully establishing and operating an

HHA limited to serving a small jurisdictional population is challenging. Creating a larger

population base for consideration of proposed HHA projects by combining two or more

contiguous jurisdictions may provide greater incentives for HHA providers to serve these less

densely populated parts of the State, providing consumers with more choices and, potentially,

higher quality choices.

Since the delivery of home health agency services does not require a resource base of buildings

or equipment, agencies have great flexibility in expanding or contracting their service capacity

and production expenses to fit the level of demand they are experiencing. As long as qualified

personnel can be recruited, HHAs have, theoretically, an infinite capacity to expand staffing

resources to absorb growth in their base of clients. There is no standard measure for determining

the minimum or maximum number of home health clients needed to support an HHA or to assure

the ability to achieve high quality performance. There is great variation in the size of HHAs in

Maryland, in terms of patient caseloads. For these reasons, this Chapter takes the approach of

regulating HHA services by emphasizing the importance of providing consumers with

meaningful choices for obtaining high quality services, in which one HHA or a small number of

HHAs do not command overwhelming dominance. It sets a benchmark of sufficient consumer

6 Baltimore metropolitan area includes the following five jurisdictions: Anne Arundel, Baltimore, Harford and

Howard Counties, and Baltimore City.


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choice as the availability of at least three high performing agencies in each jurisdiction. It targets

highly concentrated HHA markets, as measured by the Herfindahl-Hirschman Index (HHI), for

consideration of new HHA providers, through new agency establishment or expansion of

existing HHA(s). Research indicates that quality and performance scores improve over time in

more competitive markets.7

Policy 1. Promote development and expansion of HHA services to address the changing

needs of the population and the HHA marketplace by enhancing consumer choice of high

quality providers in highly concentrated markets.

Policy 2. Create the opportunity for combining certain less densely populated and

contiguous jurisdictions into regional service areas for the purpose of establishing CON

review cycles.

Policy 3. Create opportunities for HHA development in jurisdictions where there is a

limited choice of quality HHA providers.

C. Home Health Agency Quality Measures and Performance.

The adoption of standardized measures for quality and performance of home health agencies by

the Centers for Medicare and Medicaid Services (CMS) and the anticipated change in the way

CMS will pay for HHA services, using a value-based purchasing model, support the use of a

regulatory process for HHAs in Maryland designed to give the most opportunity for growth to

agencies that can demonstrate high quality and good value.

Thus, unlike previous HHA Chapters that attempted to define the need for HHA services by

focusing on rates of population demand for services and changes in population, this Chapter

identifies need for new HHA service providers on whether there is reasonable consumer choice

of quality performing HHA providers in a jurisdiction and takes the position that more good

quality choices should be encouraged when a market is dominated by a small number of

providers.

Qualifying factors for an application to be considered would depend on the type of applicant.

Existing Medicare-certified HHAs in Maryland seeking to expand and applicants with

experience in operating Medicare-certified HHAs in other states will need to demonstrate high

quality performance on the CMS Star Rating system for HHAs and Home Health Compare

measures. An applicant with no previous experience in providing HHA services but with

experience in providing RSA services (including skilled nursing care) in Maryland or in

providing hospital or nursing home services in any state will also have an opportunity to gain

7 Public Reporting as a Quality Improvement Strategy, an evidence-based report (No. 208) issued in July 2012 by

the Agency for Healthcare Research and Quality. “The Association of Nursing Home Compare Quality Measures

with Market Competition and Occupancy Rates,” published in the March/April 2008 issue of the Journal for

Healthcare Quality.


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entry to the regulatory process but will, of necessity, be allowed to offer another type of

demonstration that it has a strong quality of care track record.

Since quality measures and the art of evaluating quality are evolving, this Chapter describes the

process by which consideration of quality will be used in qualifying applicants for scheduled

review cycles. The Chapter does not include the specific quality measures, performance

thresholds, or improvement targets that will be used. Rather, these would be published for

review and comment prior to the initiation of review cycles in which applications could be filed.

After review of any comments received, the specific quality measures, performance thresholds

and improvement targets, and other qualifying criteria will be established by the Commission

and published in the Maryland Register and on the Commission’s website, along with the review

schedule. This way, the Commission can be responsive to the changing measures of quality

performance collected and reported by CMS and others.

There are generally two types of quality measures collected and publically reported for existing

Medicare-certified HHAs, process and outcome measures. Additionally, there are experience of

care measures, based on consumer evaluations of agency performance. Numerous process and

outcome measures of quality are collected using the Outcome and Assessment Information Set

(OASIS) instrument, a requirement for all Medicare-certified HHAs. OASIS consists of data

elements collected at the point of care that include the core items of a comprehensive assessment

for the home health agency client. CMS selects a subset of quality measures and calculates

agency-specific scores for each selected process and outcome measure. An agency’s

performance for each selected measure is then compared to Maryland and national average

scores.8

Experience of care measures, based on the consumers’ perspectives regarding their experiences

with the services/care received, are collected using the Home Health Consumer Assessment of

Healthcare Providers and Systems (HHCAHPS) survey. Five measures – three composite

measures and two global ratings – are derived from the HHCAHPS survey. Each of the three

composite measures consists of four or more individual survey items regarding one of the

following topics: patient care; communication between providers and patients; and specific care

issues on medications, home safety, and pain. The two global ratings are the overall rating of

care provided by the HHA, and, the patient’s willingness to recommend the HHA to family and

friends. Agency-specific scores are calculated for each of the five experience of care measures,

and are compared to the average scores for Maryland and the nation.9

8 Refer to the Commission’s White Paper (Appendix Table 12) for agency-specific scores calculated for each of the

selected 22 process and outcome measures comparing Maryland and national average scores for the 2012 and 2013

reporting years, at http://mhcc.maryland.gov/mhcc/pages/home/workgroups/workgroups_hha.aspx 9 Refer to the Commission’s White Paper (Appendix Table 13) for agency-specific scores calculated for each of the

five experience of care measures comparing Maryland and national average scores for the 2012 and 2013 reporting

years, at http://mhcc.maryland.gov/mhcc/pages/home/workgroups/workgroups_hha.aspx

http://mhcc.maryland.gov/mhcc/pages/home/workgroups/workgroups_hha.aspx

http://mhcc.maryland.gov/mhcc/pages/home/workgroups/workgroups_hha.aspx


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For an applicant not currently Medicare-certified as an HHA, but licensed and accredited as a

hospital, nursing home or Maryland RSA providing skilled nursing services, submission of

evidence of an established quality program that systematically collects process and outcome

measures comparable to Home Health Compare, and experience of care measures similar to

HHCAHPS, is required. The population being served and assessed for quality should also be

described.

Policy 4. Permit growth through the expansion of existing HHAs with high levels of

performance and permit gradual development of new agencies with documented

experience in providing high quality health care services.

Policy 5. Continue to assess, and revise as needed, the qualifying factors for jurisdictions

and applicants, to account for changes in the health care delivery and financing systems,

the needs of the population and HHA marketplace, and changes in quality measurement.

Policy 6. Streamline the CON review process by defining need and establishing docketing

and procedural rules that permit most applications that qualify for docketing to be quickly

reviewed.

D. Home Health Agency Data Collection and Public Reporting.

An HHA seeking Medicare certification is required to meet the Medicare Conditions of

Participation including, but not limited to, compliance with requirements for collecting and

reporting performance and experience of care data for Medicare and Medicaid HHA clients.

Medicare-certified HHAs are required to submit data on both the OASIS and HHCAHPS.

CMS created the Home Health Compare website as a national tool which enables consumers and

providers to compare quality and performance information across all Medicare-certified HHAs.

CMS selects a subset of process and outcome quality measures that it reports publicly on Home

Health Compare. Similarly, the Commission’s Consumer Guide to Long Term Care Services

reports Home Health Compare quality measures for each Maryland Medicare-certified HHA.

Agency-specific scores are calculated for each of the selected process and outcome measures,

and are compared to Maryland and national average scores.

CMS’ Star Ratings for HHAs are also reported on Home Health Compare, which provides

symbols and summary data to help consumers more quickly identify differences in quality and

make use of the information when selecting an HHA. In addition to summarizing performance,

Star Ratings can also help HHAs identify areas for improvement.

Such quality reporting on public websites creates the potential for greater awareness by

consumers of an HHA’s performance relative to that of other HHAs. Moreover, every HHA can

also use this data to compare its performance to that of other agencies, which can spur quality

improvement programs.


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Under COMAR 10.07.11, licensed HHAs in Maryland are required to submit an annual report in

the format prescribed by the Secretary of the Department of Health and Mental Hygiene. The

Maryland Home Health Agency Annual Report Survey, conducted by the Commission,

constitutes the format prescribed by the Secretary. The HHA Annual Survey collects utilization,

demographic, and financial information for all licensed Maryland Home Health Agencies, both

for the facility and by its authorized jurisdictions. This comprehensive database of information

reported on the Annual HHA Survey is made available to the public on the Commission’s

website.

Policy 7. Continue to collect data from all home health agency providers in order to obtain

timely, Maryland-specific data to support planning and regulation of home health agency

services.

Policy 8. Update and maintain the Commission’s Consumer Guide to Long Term Care

Services to reflect the most recent quality and performance measures collected and

reported by CMS as an important tool for aiding Maryland consumers to identify high

performing HHAs.


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.04 Need Determination for Home Health Agency Services. A jurisdiction shall be identified

as having a need for additional home health agency services if it is determined that the

jurisdiction has insufficient consumer choice of HHAs, a highly concentrated HHA service

market, or an insufficient choice of HHAs with high quality performance. A jurisdiction shall not

be identified as having need for additional home health agency services if the jurisdiction has an

existing HHA with less than three years of operational experience or has a newly authorized

HHA that has not yet been implemented.

A. Insufficient consumer choice is considered to exist in any jurisdiction in which consumers

have two or fewer Medicare-certified HHAs that served 10 or more clients each year during the

most recent three-year period for which data is available.

B. A jurisdiction is considered to have a highly concentrated HHA market when it has a

Herfindahl-Hirschman Index (HHI) of 0.25 or higher.

C. A jurisdiction is considered to have an insufficient choice of quality performing HHAs if

HHAs serving 60 percent or more of the clients in that jurisdiction in the most recent year for

which data is available, did not meet the applicable quality performance requirements designated

by the Commission. Before establishing review cycles, these quality performance requirements

will be posted for review and comment, along with the qualifying jurisdictions and any multi-

jurisdictional regions proposed for use in CON regulation. After review and consideration of the

comments, the final quality performance requirements and jurisdictions/regions established by

the Commission will be published in the Maryland Register and on the Commission’s website.


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.05 Use of Multi-Jurisdictional Regions in Certificate of Need Review of Home Health

Agency Services. The Commission may create the opportunity for the submission of CON

applications for proposed development of new HHAs or expanding the services of existing

HHAs into regional service areas composed of two or more contiguous jurisdictions. These

opportunities will only be created when the regional service area has met one of the specified

qualifying criteria for a determination of need consistent with Regulation .04 of this Chapter:

A. Any multi-jurisdictional region created for the review of CON applications will be

geographically contiguous. No jurisdiction will be included in a region that does not share a land

border with a least one other jurisdiction in the region.

B. Jurisdictions with a total population size of 300,000 or more will not be combined with other

jurisdictions to create regional service areas.

C. An applicant seeking to establish an HHA in or expand HHA services into a multi-

jurisdictional region shall meet all the applicable qualifications for an applicant described in

Regulation .06 of this Chapter and be found to be in compliance with or consistent with the CON

review standards found in Regulation .08 of this Chapter.


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.06 Certificate of Need Application Acceptance Rules: Home Health Agency Services. The

Commission will use rules in this section to determine whether an application to establish a new

home health agency (HHA) in Maryland or to expand the services of an existing Maryland HHA

to a jurisdiction that the HHA was not previously authorized to serve can be accepted for review.

The Commission will only review and issue decisions to approve or deny docketed applications.

A. Jurisdictional Need.

(1)The Commission will not accept an application for establishment of a new HHA in

Maryland, or an expansion of the services of an existing Maryland HHA, unless there is an

identified need for additional HHA services in the jurisdiction proposed for such agency

establishment or expansion, in accordance with the need determination rules described in

Regulation .04.

(2) The Commission will not accept an application for establishment of a new HHA in

Maryland proposing to serve a multi-jurisdictional region, or an expansion of the services of an

existing Maryland HHA into a multi-jurisdictional region, unless there is an identified need for

additional HHA services in the multi-jurisdictional region proposed for such agency

establishment or expansion, in accordance with the rules described in Regulation .05 of this

Chapter.

B. Qualified Applicants. The Commission will accept an application from applicants that meet

applicable qualifications. An applicant shall apply as one of three types of applicants:

(1) Existing Medicare-certified HHA licensed in Maryland and proposing to add one or

more jurisdictions to its authorized service area;

(2) Existing Medicare-certified HHA licensed in another state and proposing to establish

a new HHA in Maryland; or

(3) Non-HHA service providers currently licensed and accredited, in good standing, as a

hospital, a nursing home, or a Maryland residential service agency (RSA) providing skilled

nursing services, and proposing to establish a new HHA in Maryland.

C. Qualifications for All Applicants. The Commission will only accept a CON application

submitted by an applicant that:

(1) Has not had its Medicare or Medicaid payments suspended within the last five years;

(2) Has not been convicted of Medicare or Medicaid fraud or abuse within the last five

years;


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(3) Has received at least satisfactory findings reflecting no adverse citations on the most

recent two survey cycles from its respective state agency or accreditation organization, as

applicable;

(4) Has submitted an acceptable plan of correction for any valid and serious patient-

related complaint investigated over the past three years;

(5) Has complied with all applicable federal and State quality of care reporting

requirements and performance standards;

(6) Can document availability of sufficient financial resources to implement the proposed

project within the applicable timeframes set forth in the Commission’s performance

requirements at COMAR 10.24.01.12.

(7) Demonstrates a record of serving all applicable payer types, such as Medicare,

Medicaid, private insurance, HMOs, and self-pay patients; and

(8) Affirms under penalties of perjury, that none of its owners or senior management or

an owner or senior management of any related or affiliated entity has been convicted of a felony

or crime or pleaded guilty, nolo contendere, entered a best interest plea of guilty, or received a

diversionary disposition regarding a felony or crime.

D. Performance-Related Qualifications. In addition to meeting the qualifications required for

all applicants described in Regulation .06C of this Chapter, performance-related qualifications

necessary for accepting an application will vary by type of applicant. The specific quality

measures used to assess an applicant’s performance and to determine qualification for acceptance

will be addressed in a process used to set these qualifications for any given review cycle, as

detailed in Regulation .07 of this Chapter. The notice provided by the Commission in the

Maryland Register and on its website will include, at a minimum:

(1) Quality measures that will be used to define a quality provider, for purposes of

accepting CON applications;

(2) Performance levels that will be required to be achieved for the identified quality

measures by prospective CON applicants in order for its application to be accepted; and

(3) The format of the performance measurement information to be submitted by non-

HHA applicants.


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.07 Establishment of HHA Quality Measures and Performance Levels for Applicants.

A. Review and Comment on Quality Measures, Performance Levels, and Public Notice.

When one or more jurisdictions has need identified for additional home health agency services

consistent with Regulation .04, Commission staff shall publish draft quality measures and

required performance levels for those quality measures that must be achieved by an applicant in

order to be considered in the review cycle. The experience of Maryland HHAs will be used to

select performance levels. The Commission will consider the comments and Commission staff’s

recommendation in establishing the applicable quality measures and performance levels for a

given review cycle.

B. Quality Measures for Maryland Medicare-certified HHAs. In order for an application

from a Maryland Medicare-certified HHA to be accepted for a scheduled review cycle, it shall:

(1) Achieve the specified rating on the CMS Star Rating system;

(2) Achieve the specified performance level on selected process and outcome measures

from CMS’ Home Health Compare for the most recent 12-month reporting period; and

(3) Demonstrate that it has maintained or improved its level of performance on the

selected process and outcome measures during the most recent three-year reporting period.

C. Quality Measures for Non-Maryland Medicare-certified HHAs. In order for an

application from a non-Maryland Medicare-certified HHA that has operated a licensed and

Medicare-certified HHA in a state other than Maryland to be accepted for a scheduled review

cycle, it shall:

(1) Achieve the specified rating on the CMS Star Rating system;

(2) Achieve the specified performance level on selected process and outcome measures

from CMS’ Home Health Compare for the most recent 12-month reporting period; and

(3) Demonstrate that it has maintained or improved its level of performance on the

selected process and outcome measures during the most recent three-year reporting period.

D. Quality Measures for Licensed and Accredited Hospital, Nursing Home, or Maryland

Residential Service Agency (RSA) Providing Skilled Nursing Services. In order for an

application to be accepted for a scheduled review cycle by an applicant that has not operated an

HHA in Maryland or any state, but has operated a hospital or nursing home in any state or has

operated an RSA in Maryland consistent with the requirements of Subsection .06B(3), it must

provide evidence that:


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(1) In the case of a Maryland licensed RSA applicant, it has operated with an established

quality assurance program that includes systematic collection of process and outcome measures,

and experience of care measures and has been accredited for at least the three most recent years

by an accreditation organization recognized by DHMH as providing deemed status for Medicare

and Medicaid certification;

(2) In the case of a hospital applicant, it has achieved and maintained the minimum CMS

Star Ratings required by the Commission for the applicable review cycle for its hospital and for

hospitals related to the system, if any, with which it is affiliated for at least the three most recent

years of operation; or

(3) In the case of a nursing home applicant it has achieved and maintained the minimum

CMS Star Ratings required by the Commission for the applicable review cycle for its nursing

home and for all nursing homes related to the system, if any, with which it is affiliated for at

least the three most recent years of operation.


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.08 Certificate of Need Review Standards for Home Health Agency Services. The

Commission shall use the following standards, as applicable, to review an application for a

Certificate of Need to establish a new home health agency in Maryland or expand the services of

an existing Maryland home health agency to one or more additional jurisdictions.

A. Service Area. An applicant shall:

(1) Designate the jurisdiction or jurisdictions in which it proposes to provide home

health agency services; and

(2) Provide an overall description of the configuration of the parent home health agency

and its interrelationships, including the designation and location of its main office, each subunit,

and each branch, as defined in this Chapter, or other major administrative offices recognized by

Medicare.

B. Populations and Services. An applicant shall describe the population to be served and the

specific services it will provide.

C. Financial Accessibility. An applicant shall be or agree to become licensed and to maintain

Medicare- and Medicaid-certification, and agree to accept clients whose expected primary source

of payment is either or both of these programs.

D. Fees and Time Payment Plan. An applicant shall make its fees known to prospective

clients and their families at time of patient assessment before services are provided and shall:

(1) Describe its special time payment plans for an individual who is unable to make full

payment at the time services are rendered; and

(2) Submit to the Commission and to each client a written copy of its policy detailing

time payment options and mechanisms for clients to arrange for time payment.

E. Charity Care and Sliding Fee Scale. Each applicant for home health agency services shall

have a written policy for the provision of charity care for indigent and uninsured patients to

ensure access to home health agency services regardless of an individual’s ability to pay and

shall provide home health agency services on a charitable basis to qualified indigent and low

income persons consistent with this policy. The policy shall include provisions for, at a

minimum, the following:

(1) Determination of Eligibility for Charity Care and Reduced Fees. Within two business

days following a client’s initial request for charity care services, application for medical

assistance, or both, the home health agency shall make a determination of probable eligibility for

medical assistance, charity care, and reduced fees, and communicate this probable eligibility

determination to the client.


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(2) Notice of Charity Care and Sliding Fee Scale Policies. Public notice and information

regarding the home health agency’s charity care and sliding fee scale policies shall be

disseminated, on an annual basis, through methods designed to best reach the population in the

HHA’s service area, and in a format understandable by the service area population. Notices

regarding the HHA’s charity care and sliding fee scale policies shall be posted in the business

office of the HHA and on the HHA’s website, if such a site is maintained. Prior to the provision

of HHA services, a HHA shall address clients’ or clients’ families concerns with payment for

HHA services, and provide individual notice regarding the HHA’s charity care and sliding fee

scale policies to the client and family.

(3) Discounted Care Based on a Sliding Fee Scale and Time Payment Plan Policy. Each

HHA’s charity care policy shall include provisions for a sliding fee scale and time payment plans

for low-income clients who do not qualify for full charity care, but are unable to bear the full

cost of services.

(4) Policy Provisions. An applicant proposing to establish a home health agency or

expand home health agency services to a previously unauthorized jurisdiction shall make a

commitment to, at a minimum, provide an amount of charity care equivalent to the average

amount of charity care provided by home health agencies in the jurisdiction or multi-

jurisdictional region it proposes to serve during the most recent year for which data is available.

The applicant shall demonstrate that:

(a) Its track record in the provision of charity care services, if any, supports the

credibility of its commitment; and

(b) It has a specific plan for achieving the level of charity care to which it

is committed.

F. Financial Feasibility. An applicant shall submit financial projections for its proposed

project that must be accompanied by a statement containing the assumptions used to develop

projections for its operating revenues and costs. Each applicant must document that:

(1) Utilization projections are consistent with observed historic trends of HHAs in each

jurisdiction for which the applicant seeks authority to provide home health agency services;

(2). Projected revenue estimates are consistent with current or anticipated charge levels,

rates of reimbursement, contractual adjustments and discounts, bad debt, and charity care

provision, as experienced by the applicant if an existing HHA or, if a proposed new HHA,

consistent with the recent experience of other Maryland HHAs serving each proposed

jurisdiction; and

(3) Staffing and overall expense projections are consistent with utilization projections

and are based on current expenditure levels and reasonably anticipated future staffing levels as


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experienced by the applicant if an existing HHA or, if a proposed new HHA, consistent with the

recent experience of other Maryland HHAs serving the each proposed jurisdiction.

G. Impact. An applicant shall address the impact of its proposed home health agency service on

each existing home health agency authorized to serve each jurisdiction or regional service area

affected by the proposed project. This shall include impact on existing HHAs’ caseloads, staffing

and payor mix.

H. Financial Solvency. An applicant shall document the availability of financial resources

necessary to sustain the project. Documentation shall demonstrate an applicant’s ability to

comply with the capital reserve and other solvency requirements specified by CMS for a

Medicare-certified home health agency.

I. Linkages with Other Service Providers. An applicant shall document its links with

hospitals, nursing homes, continuing care retirement communities, hospice programs, assisted

living providers, Adult Evaluation and Review Services, adult day care programs, the local

Department of Social Services, and home-delivered meal programs located within its proposed

service area.

(1) A new home health agency shall provide this documentation when it requests first use

approval.

(2) A Maryland home health agency already licensed and operating shall provide

documentation of these linkages in its existing service area and document its work in forming

such linkages before beginning operation in each new jurisdiction it is authorized to serve.

J. Discharge Planning. An applicant shall document that it has a formal discharge planning

process including the ability to provide appropriate referrals to maintain continuity of care. It

will identify all the valid reasons upon which it may discharge clients or transfer clients to

another health care facility or program.

K. Data Collection and Submission. An applicant shall demonstrate ongoing compliance or

ability to comply with all applicable federal and State data collection and reporting requirements

including, but not limited to, the Commission’s Home Health Agency Annual Survey, CMS’

Outcome and Assessment Information Set (OASIS), and CMS’ Home Health Consumer

Assessment of Healthcare Providers (HHCAHPS)


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.09 Certificate of Need Preference Rules in Comparative Reviews. Consistent with COMAR

10.24.01.09A(4)(b), the Commission shall use the following preferences, in the order listed, to

limit the number of CON applications approved in a comparative review:

A. Performance on Quality Measures. Higher levels of performance will be given preference

over lower levels of performance.

B. Proven Track Record in Serving all Payor Types, the Indigent and Low Income

Persons. Serving a broader range of payor types and the indigent will be given preference over

service to a narrower range of payor types and less service to the indigent and low income

persons.

C. Proven Track Record in Providing a Comprehensive Array of Services. Providing a

broader range of services will be given preference over providing a narrower range of services.

D. These preferences will only be used in a comparative review of applications when it is

determined that approval of all applications that fully comply with standards in Regulation .08 of

this Chapter would exceed the permitted number of additional HHAs provided for in a

jurisdiction or multi-jurisdictional region as described for in Regulation .10.


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.10 Gradual Entry of New Market Entrants. In order to allow for gradual entry of new

entrants into a jurisdiction or multi-jurisdictional region without excessive disruption or

destabilization of the existing HHA staffing resources, the Commission will limit the number of

new entrants authorized by CON approval under any given review cycle to:

A. No more than 40 percent of the number of existing HHAs in a jurisdiction or multi-

jurisdictional region with four or more agencies; and

B. No more than one additional HHA in a jurisdiction or multi-jurisdictional region with fewer

than four existing HHAs.


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.11 Acquisition of a Home Health Agency. The following additional rules will be used in

consideration of a request for determination of coverage under COMAR 10.24.01.03A regarding

the proposed acquisition of an HHA.

A. Acquisition of Authority to Serve Jurisdictions.

(1) The purchaser of a freestanding HHA shall acquire the authority to serve each

jurisdiction which the HHA being acquired has been authorized to serve.

(2) The purchaser of a hospital-based HHA shall only acquire the authority to serve the

residents in the jurisdiction in which the hospital-based agency’s parent hospital is located,

unless the hospital-based agency has obtained authority to serve other jurisdictions through

issuance of a CON or earlier acquisition of an existing HHA. The purchaser will not acquire the

authority to follow patients to any jurisdiction after discharge from the parent hospital of the

HHA, unless the HHA is being acquired as part of an acquisition of the parent hospital.

B. Persons Who May Acquire an HHA. An HHA may not be acquired by an entity with an

owner or member of senior management or an owner or member of senior management of a

related or affiliated entity who has been convicted of a felony or crime or pleaded guilty, nolo

contendere, entered a best interests plea of guilty, or received a diversionary disposition

regarding a felony or crime within the last five years, unless all the individuals involved in the

fraud or abuse are no longer working for the HHA and the HHA has fully complied with each

applicable plan of correction.

C. Commitment to Serve All Payor Types and the Uninsured. A purchaser of an HHA shall

commit to serving Medicare, Medicaid, commercial, self-pay and uninsured clients, as well as to

providing charitable services and reduced charge services for indigent and low income clients.

This commitment shall be explicitly stated by the purchaser, and will be identified in the

determination of coverage issued for the HHA acquisition.

D. Acquisition of the Entire HHA. An HHA can only be acquired in its entirety. Authority to

serve jurisdictions that an HHA has been authorized to serve cannot be sold or acquired except in

the case of an acquisition of an entire HHA.

E. Acquisition of an HHA with Ongoing CON Conditions. The purchaser of an HHA with an

ongoing CON condition shall commit to meeting each condition in its operation of the acquired

HHA.

F. Information Required for a Determination of Coverage for an HHA Acquisition. The

Commission requires the following information from the purchaser and seller of an HHA, in

addition to information required under COMAR 10.24.01.03A:


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(1). A purchaser shall affirm that the services historically provided by the HHA being

acquired will not change as a result of the proposed acquisition;

(2) A purchaser shall provide information on corporate structure and affiliations of the

purchaser, the purchase price, and the source of funds;

(3) A purchaser shall disclose whether any of its principals or a principal of a related

entity has ever pled guilty to, been convicted of, or received a diversionary disposition for a

felony within the last five years;

(4) A purchaser shall disclose any record of Medicare or Medicaid fraud or abuse;

(5) A purchaser shall agree to maintain Medicare and Medicaid certification;

(6) A purchaser shall indicate whether it is maintaining the seller’s Medicare provider

agreement and, if not, it shall provide a plan for operating the HHA prior to obtaining Medicare

certification within 18 months of the acquisition;

(7) If the purchaser is an existing provider of Medicare-certified HHA services, whether

in Maryland or another state, it shall disclose deficiencies cited by the applicable state agency or

accreditation organization for the most recent two survey cycles and document completion of

any required plan of correction; and

(8) The seller and the purchaser shall agree to collaborate in providing a full 12-months

of data to the Commission’s Annual HHA Survey for the reporting year in which the acquisition

occurs and the purchaser shall agree to participate in the Annual HHA Survey going forward.


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.12 Merger or Consolidation of HHAs. The Commission will use the following rules to

consider requests for an exemption from CON to merge or consolidate two or more HHAs, in

addition to the requirements at COMAR 10.24.01.04.

A. Jurisdictional Authority.

(1) Freestanding HHAs that merge or consolidate shall combine authorized jurisdictions

as the resulting service area.

(2) A merger with a hospital-based HHA shall result in the surviving entity acquiring

from the hospital-based HHA only the authority to serve the residents in the jurisdiction in which

the hospital-based HHA’s parent hospital is located, unless such hospital-based HHA obtained

authority to serve other jurisdictions through issuance of a CON or earlier acquisition of an

existing HHA. Merger or consolidation of a hospital-based HHA with another HHA will not

provide the resulting entity with authority to follow patients to any jurisdiction after discharge

from the parent hospital of the former hospital-based HHA, unless the hospital-based HHA is

part of an overall merger or consolidation of the parent hospital.

B. Commitment to Serve All Payor Types and Uninsured. In a proposed merger of two or

more HHAs, the resulting entity shall commit to serve Medicare, Medicaid, commercial, self-pay

and uninsured clients, as well as to provide charitable service and reduced charge service for the

indigent, following the merger. This commitment shall be explicitly stated by the merging

entities and will be a condition of the exemption from CON.

C. Merger of HHAs with Ongoing CON Conditions. Should one or more of the merging

HHAs have one or more ongoing CON conditions, the HHA surviving the merger shall commit

to compliance with each such condition in its operation of the HHA surviving the merger.

D. Public Interest Finding. In determining whether a proposed merger or consolidation of two

or more HHAs is in the public interest, the Commission will consider appropriate factors

including: geographic and financial access; market concentration pre- and post- merger based on

Herfindahl-Hirschman Index (HHI); and quality performance of the surviving entity.


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.13 Definitions.

A. In this Chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) Accreditation organization means a recognized professional accrediting agency

responsible for ensuring that healthcare organizations meet predetermined criteria and standards

of quality.

(1) Acquisition means any transfer of stock or assets that results in a change of the

person or persons who control the home health agency, or the transfer of any stock or ownership

interest in excess of 25 percent.

(2) Adult day care center means a planned program of services provided in a protective

group setting licensed by the Maryland Department of Health and Mental Hygiene that provides

services which improve or maintain health or functioning and social activities for seniors and

persons with disabilities The services offered can vary but are designed to meet the needs of

participants during the day, while allowing individuals to continue living with their families or in

the community. Examples of services provided include physical and speech therapy, medication

management, mental health services, and support groups.

(3) Adult Evaluation and Review Services (AERS) means a Maryland Medicaid program

that provides comprehensive evaluations for aged and functionally disabled adults who need long

term care and are at risk for institutionalization. AERS staff are nurses and social workers who

identify services that can help individuals either remain in the community or in the least

restrictive environment where they are able to function at the highest possible level of

independence.

(4) Assisted living program means a residential or facility-based program licensed under

COMAR 10.07.14 that provides housing and supportive services, supervision, personalized

assistance, health-related services, or a combination of those services to meet the needs of

residents who are unable to perform, or who need assistance in performing, the activities of daily

living or instrumental activities of daily living, in a way that promotes optimum dignity and

independence for the residents.

(5) Branch means an office (previously known as a “satellite” office) of a parent home

health agency or subunit that is located at a different site, but is sufficiently close to share

administration, supervision and services with the parent agency or subunit on a daily basis. A

branch is not autonomous from the parent home health agency or subunit.

(6) Charity care.

(a) Charity care means care for which there is no means of payment by the patient

or any third-party payer.


26


(b) Charity care does not mean uninsured or partially insured days of care

designated as deductibles or co-payments in patient insurance plans, nor that portion of charges

not paid as a consequence of either a contract or agreement between a provider and an insurer,

or a waiver of payment due to family relationship, friendship, or professional courtesy. Charity

care does not include bad debt.

(7) Client means an individual who has been receiving or may receive home health

agency services.

(8) Community-based long term care services means services delivered to functionally

disabled persons in their communities to help meet their needs for health care and social support,

to enable them to achieve or maintain an optimal degree of independence, and to improve their

quality of life.

(9) Consumer Assessment of Healthcare Providers and Systems (CAHPS®) means a

standardized series of surveys, developed by the Agency for Healthcare Research and Quality

(AHRQ), which ask consumers and patients to report on and evaluate their experiences with

health care providers. Home Health CAHPS® is designed to measure the experiences of people

receiving home health care from Medicare-certified home health agencies.

(10) Contiguous jurisdiction means a jurisdiction which geographically shares a land

boundary with that of another jurisdiction’s land boundary. Distinct jurisdictions separated by a

body of water are not considered contiguous jurisdictions, as the perimeters of the jurisdictions

are not joined by common land boundaries.

(11) Continuing care means providing shelter plus health services consistent with the

requirements of the laws located at Title 10, Subtitle 4, of the Human Services Article,

Annotated Code of Maryland, and Code of Maryland Regulations (COMAR) 32.02.01.

According to the Maryland Department of Aging, although the legal definition of “continuing

care” is complex, in general, “continuing care” exists when all three of the following are present:

(a) The consumer pays an entrance fee that is, at a minimum, three times the

average monthly fee;

(b) The provider furnishes or makes available shelter and health-related services

to persons 60 years of age or older; and

(c) The shelter and services are offered under a contract that lasts for a period of

more than one year, usually for life.

(12) Continuing care retirement community (CCRC) means a legally organized entity

to provide continuing care in a facility that has been certified by the Maryland Department of

Aging.


27


(13) Freestanding home health agency means a licensed home health agency that is an

independent business not directly operated as a department of a hospital, nursing home, or other

type of facility.

(14) General home health agency means a licensed home health agency that provides a

full range of home health services.

(15) Herfindahl-Hirschman Index (HHI) is a measure of the size of firms (HHAs) in

relation to the overall HHA industry and an indicator of the amount of competition among them.

It is defined as the sum of the squares of the market shares of all the HHAs authorized and

actually serving a jurisdiction. Results can range from 0 to 1.0; a competition index of 1.0

indicates a monopoly or a totally concentrated market. Conversely, a competition index close to

0 generally indicates a fair share of the market among an increasing number of HHA providers

and, thus, an HHA market offering greater access to a variety of HHA providers. (Note: the

competition index is divided by 10,000 for ease of interpretation.)

(16) Highly concentrated market means having an HHI measure greater than 2,500 (0.25

when dividing by 10,000) according to the U.S. Department of Justice (DOJ) and the Federal

Trade Commission (FTC) 2010 Horizontal Merger Guidelines.

(17) Home health agency.

(a) “Home health agency” means a health-related organization, institution, or part

of an institution that directly, or through a contractual arrangement, provides to a sick or disabled

individual in the residence of that individual skilled nursing and home health aide services, and

at least one other home health care service that is centrally administered, as provided under

Health-General Article, § 19-401, et seq., Annotated Code of Maryland.

(b) “Home health agency” includes both parent (previously known as branch) and

subunit, as defined by the Centers for Medicare and Medicaid Services in 42 CFR §484.2.

(c) “Home health agency” does not mean a residential service agency as defined

in Health-General Article, §19-4A, Annotated Code of Maryland.

(18) Home Health Agency Service means any or all of the following services that are

provided in accordance with Health-General Article, §19-401, Annotated Code of Maryland,

under the general direction of licensed health professionals practicing within the scope of their

practice acts:

(a) Audiology and speech pathology;

(b) Dietary and nutritional services;

(c) Drug services;

(d) Home health aide;

(e) Laboratory services;

(f) Medical social services;

(g) Skilled nursing;


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(h) Occupational therapy;

(i) Physical therapy; and

(j) Provision of medically necessary sick room equipment and supplies.

(19) Home Health Compare means a website created and maintained by the Centers for

Medicare & Medicaid Services (CMS). Home Health Compare contains information about the

quality of care provided by Medicare-certified home health agencies throughout the nation.

Quality measures displayed on Home Heath Compare include process, outcome, and experience

of care measures.

(20) Hospice care program.

(a) General hospice care program means a coordinated, interdisciplinary

program provided in accordance with Health-General Article, §19-901, and regulations under

COMAR 10.07.21 meeting the special physical, psychological, spiritual, and social needs of

dying individuals and their families by providing palliative and supportive medical, nursing, and

other health services through home or inpatient care during the illness and bereavement to:

(i) Individuals who have no reasonable prospect of cure as estimated by a

physician; and

(ii) Families of those individuals.

(b) Limited hospice care program means a coordinated, interdisciplinary

program of provided in accordance with Health-General Article, §19-901, Annotated Code of

Maryland, and regulations under COMAR 10.07.21 to meet the special physical, psychological,

spiritual, and social needs of dying individuals and their families, by providing palliative and

supportive non-skilled services through a home-based hospice care program during illness and

bereavement to individuals who have no reasonable prospect of cure as estimated by a physician

and to the families of those individuals.

(21) Hospital-based home health agency means a home health agency directly

operated as a department of a hospital whose cost report data is included as part of a hospital’s

overall cost report.

(22) Indigent means a person whose annual income, based on the number of persons in

the family, falls within the most recently published poverty guidelines of the U.S. Department of

Health and Human Services.

(23) Jurisdiction means any of the 23 Maryland counties or Baltimore City.

(24) Licensed means a facility that has received approval to operate from the Office of

Health Care Quality of the Maryland Department of Health and Mental Hygiene.


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(25) Long term care means the array of medical, social, and support services needed

by individuals who, because of chronic illness or disability, need another person's help in caring

for themselves over an extended period of time.

(26) Low income: “a low-income person” is a person whose annual income, based on the

number of persons in the family, falls above the most recently published poverty guidelines of

the U.S. Department of Health and Human Services but below 200 percent of the poverty

guideline.

(27) Medicaid means the Maryland Medical Assistance Program administered by the

State under Title XIX of the Social Security Act to reimburse comprehensive medical and other

health-related care for categorically eligible and medically needy persons.

(28) Medicare means the federal health insurance program administered under Title

XVIII of the Social Security Act that pays for certain health care expenses for people who are 65

years or older, certain younger people with disabilities, and people with end-stage renal disease.

(29) Nursing home means a health care facility licensed for comprehensive care beds

under COMAR 10.07.02 that admits patients suffering from disease or disabilities, or advanced

age, requiring medical service and nursing service rendered by or under the supervision of a

registered nurse.

(30) Nursing referral service agency means one or more individuals licensed consistent

with COMAR 10.07.07 and engaged in the business of screening and referring, directly or in

accordance with contractual arrangements that may include independent contractors, licensed

health professionals or care providers to clients for the provision of nursing services, home

health aide services, or other home health care services at the request of the clients.

(31) Outcome Assessment Information Set (OASIS) means a group of standard data

elements developed, tested and refined through extensive research by the Centers for Medicare

and Medicaid Services. OASIS data elements are designed to enable comparative measurement

of home health care patient outcomes, with appropriate adjustment for patient risk factors

affecting those outcomes. Data is collected for adult skilled Medicare and Medicaid home health

care patients. OASIS data items address sociodemographic, environmental, support system,

health status, functional status, and health service utilization characteristics of the patient. The

data are collected at start of care, 60-day follow-ups, and discharge (and surrounding an inpatient

facility stay). Selected outcome measures derived from OASIS are reported for Medicare-

certified home health agencies on the federal website Home Health Compare.

(32) Parent home health agency means the home health agency that develops and

maintains administrative controls of subunits and branch offices.

(33) Person means an individual, receiver, trustee, guardian, executor, administrator,

fiduciary, or representative of any kind and any partnership, firm, association, limited liability

company, limited liability partnership, public or private corporation, or other entity.


30


(34) Regional service area means a multi-jurisdictional region for the purpose of creating

a larger population base for consideration of proposed HHA projects by combining two or more

jurisdictions which are geographically contiguous. Jurisdictions with a total population size of

300,000 or more will not be combined with other jurisdictions to create regional service areas.

.

(35) Residential service agency (RSA) means an individual, partnership, firm,

association, corporation, or other entity of any kind and licensed in accordance with COMAR

10.07.05 that is engaged in a nongovernmental business of employing or contracting with

individuals to provide at least one home health care service, as defined in Health-General Article,

§19-4A-01, Annotated Code of Maryland,.for compensation to an unrelated sick or disabled

individual in the residence of that individual or an agency that employs or contracts with

individuals directly for hire as home health care providers

(36) Skilled care means a service or services that may be provided only by an individual

who:

(a) Is licensed under Health Occupations Article, Annotated Code of Maryland,

and

(b) Exercises specialized knowledge, judgment, and skill.

(37) Subunit means a semi-autonomous independent entity of a parent home health

agency that is located at such a distance from the parent agency that it is incapable of sharing

administration, supervision, and services on a daily basis. A subunit serves home health clients

in a different geographic area from the parent agency.

Documents

DRAFT: FOR INFORMAL PUBLIC COMMENT STATE …mhcc.maryland.gov/.../home/...Chapter_for_Informal_Public_Comments.pdfFACILITIES AND SERVICES: HOME HEALTH AGENCY SERVICES ... E. Overview